PSYCHOSOCIAL STIMULATIONS and TREATMENT OUTCOME of SEVERE ACUTE MALNOURISHED CHILDREN

NCT ID: NCT06653790

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-04-10

Brief Summary

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A playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the SAM children in play-based motor, language, and personal-social activities. The severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

Detailed Description

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The World Health Organisation (WHO) also suggests including psychological stimulation in the treatment of severe acute malnutrition. However, there is limited evidence that these interventions are beneficial for SAM children, especially when there are severe food shortages and a lack of a balanced diet.

There is limited available research in Pakistan examining the impact of psychosocial stimulation on severely malnourished children and a significant gap in its implementation. It is obvious that current implementation research is needed to understand how to improve brain development in children with SAM who require inpatient care in a practical and pragmatic approach.

The purpose of this study is to present data on the efficacy of these therapies, which may help shape future SAM treatment plans and policies. Mitigating the physical and mental dimensions of malnourishment can result in more enduring and significant consequences, ultimately enhancing the standard of living for millions of children around the globe.

Conditions

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Malnutrition Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The severely acute malnourished children in intervention group will be sent to development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational and a physiotherapist will also be available for sessions. The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge, patient will be referred to outpatient (at outpatient therapeutic center) and developmental outpatient. The sessions with development pediatrician and team will be held every week lasting for about 20-40 min in the presence of the caregiver. The intervention includes auditory, tactile and visual stimulation, hand-eye coordination, and different types of sensory-motor training that include fine and gross motor activities. The guiding principle will be to enhance a child's holistic development-cognitive, language, physical, and social-in an integrated manner by using age-appropriate play materials, cultural t
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Investigators
The care provider and investigators will be blided

Study Groups

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Intervention arm

The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge patient will be referred to out-patient (at outpatient therapeutic centre) and developmental out-patient. The sessions with development paediatrician and team will be held every week lasting for about 20-40 min in the presence of the caregiver. The intervention includes auditory, tactile and visual stimulation, hand-eye coordination, and different types of sensory-motor training that included fine and gross motor activities. The guiding principle will be to enhance a child's holistic development-cognitive, language, physical, and social-in an integrated manner by using age-appropriate play materials, cultural tools, and resources.

Group Type EXPERIMENTAL

Psychosocial stimulations

Intervention Type BEHAVIORAL

The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge patient will be referred to out-patient (at outpatient therapeutic centre) and developmental out-patient. The sessions with development paediatrician and team will be held every week lasting for about 20-40 min in the presence of the caregiver. The intervention includes auditory, tactile and visual stimulation, hand-eye coordination, and different types of sensory-motor training that included fine and gross motor activities. The guiding principle will be to enhance a child's holistic development-cognitive, language, physical, and social-in an integrated manner by using age-appropriate play materials, cultural tools, and resources.

Control

The control arm will be given no intervention except standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychosocial stimulations

The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge patient will be referred to out-patient (at outpatient therapeutic centre) and developmental out-patient. The sessions with development paediatrician and team will be held every week lasting for about 20-40 min in the presence of the caregiver. The intervention includes auditory, tactile and visual stimulation, hand-eye coordination, and different types of sensory-motor training that included fine and gross motor activities. The guiding principle will be to enhance a child's holistic development-cognitive, language, physical, and social-in an integrated manner by using age-appropriate play materials, cultural tools, and resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All children aged 6m to 59 months admitted to stabilization centre fulfilling criteria of severe acute malnutrition will be included in study.

Exclusion Criteria

* Children with chronic diseases like cystic fibrosis, cerebral palsy, celiac disease, chronic kidney disease, chronic liver failure, congenital heart disease, inborn error of metabolism, cleft lip and palate will be excluded from study.
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Arshed Muhammad

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Nabeela Mushtaq, MBBS, FCPS

Role: CONTACT

00923324292532

Muhammad Arshed, MBBS, MPH,PhD

Role: CONTACT

00923337474464

References

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Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3.

Reference Type BACKGROUND
PMID: 18772893 (View on PubMed)

Yousafzai AK, Obradovic J, Rasheed MA, Rizvi A, Portilla XA, Tirado-Strayer N, Siyal S, Memon U. Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial. Lancet Glob Health. 2016 Aug;4(8):e548-58. doi: 10.1016/S2214-109X(16)30100-0. Epub 2016 Jun 21.

Reference Type BACKGROUND
PMID: 27342433 (View on PubMed)

Worku BN, Abessa TG, Wondafrash M, Vanvuchelen M, Bruckers L, Kolsteren P, Granitzer M. The relationship of undernutrition/psychosocial factors and developmental outcomes of children in extreme poverty in Ethiopia. BMC Pediatr. 2018 Feb 9;18(1):45. doi: 10.1186/s12887-018-1009-y.

Reference Type BACKGROUND
PMID: 29426302 (View on PubMed)

Ethiopian FMoH. Job aid for maternal nutrition and age Appropriate Infant & Young Child Nutrition: Addis Ababa; 2016.

Reference Type BACKGROUND

Other Identifiers

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BMU-HS

Identifier Type: -

Identifier Source: org_study_id

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